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510(k) K884835

TASSI MK2 by Therapy Air Support Systems, Inc. — Product Code INX

K884835 is an FDA 510(k) premarket notification submitted by Therapy Air Support Systems, Inc. for the device "TASSI MK2". The FDA issued a decision of Substantially Equivalent on December 7, 1988. The device falls under product code INX (Bed, Air Fluidized), a Class II device regulated under 21 CFR 890.5160. Therapy Air Support Systems, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1988
Date Received
November 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Air Fluidized
Device Class
Class II
Regulation Number
890.5160
Review Panel
PM
Submission Type

Other clearances by Therapy Air Support Systems, Inc.

  • K910851 — TASSI MK3 (TURNAIR) (May 15, 1991)

Other clearances for product code INX

  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K964223 — CLINITRON RITE-HITE (May 28, 1997)
  • K943385 — CLINITRON ELEXIS (February 27, 1995)
  • K942184 — CLINITRON AT HOME AIR FLUIDED THERAPY (February 7, 1995)
  • K931168 — X-20 AIR SUPPORT BED (February 17, 1994)
  • K934689 — LOW AIR LOSS MATTRESS, MODIFICATION (February 2, 1994)
  • K924973 — DYLNAMEDICS A.S.A.P. (October 15, 1993)
  • K926402 — COMFORT CARE LOW AIR LOSS THERAPY BED (March 24, 1993)
  • K924686 — REM-AIR (February 12, 1993)
  • K920112 — CLINITRON C-II (January 24, 1992)

FDA data resources